Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by National and Kapodistrian University of Athens
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01315093
First received: March 8, 2011
Last updated: April 6, 2016
Last verified: March 2016

March 8, 2011
April 6, 2016
November 2010
June 2016   (final data collection date for primary outcome measure)
no of oocytes retrieved [ Time Frame: egg recovery, 2 years ] [ Designated as safety issue: No ]
>2 between groups
Οngoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The presence of fetal heart on ultrasound after 12 weeks of gestation
Complete list of historical versions of study NCT01315093 on ClinicalTrials.gov Archive Site
  • clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
  • live birth rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    >20 weeks of gestation
  • cancellation rate [ Time Frame: before ET, 2 years ] [ Designated as safety issue: No ]
  • miscarriage rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    pregnancy loss <20 weeks
Evidence and rate of clinical pregnancy [ Time Frame: 6+2 gestational weeks ] [ Designated as safety issue: No ]
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
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The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)
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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Infertility
  • Drug: Heparin, Low-Molecular-Weight
    Heparin from start till hcg test
  • Drug: no heparin
  • Experimental: Heparin, Low-Molecular-Weight group
    LMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation
    Intervention: Drug: Heparin, Low-Molecular-Weight
  • Active Comparator: Non Heparin, Low-Molecular-Weight group
    IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.
    Intervention: Drug: no heparin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • poor responders (age>40, abnormal ovarian test, </=4 oocytes in previous cycle with conventional stimulation)
  • infertility, indication for IVF
  • no contraindications for heparin
Female
25 Years to 43 Years   (Adult)
Yes
Contact: Charalampos S Siristatidis, Ass Professor 6932294994 ext 0030 harrysiri@yahoo.gr
Greece
 
NCT01315093
123456
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Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
National and Kapodistrian University of Athens
Not Provided
Not Provided
National and Kapodistrian University of Athens
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP